MAUDE Adverse Event Report: MEDTRONIC ADVANCED ENERGY, LLC MICROPITUITARY RONGEUR 9569565; INSTRUMENT, CUTTING, RONGEUR

Model Number 9569565

Device Problem Material Fragmentation (1261)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/19/2017

Event Type  Injury  

Event Description

During a posterior spinal fusion, a micropituitary rongeur broke.It was not discovered that some pieces were missing from this instrument until it was put back on the tray.Some pieces recovered on back table.X-ray ordered.X-ray read as negative.Manufacturer: please note that we do not send products to the manufacturer, but you may arrange for pick-up by sending an e-mail to the address below.

• Brand Name: MICROPITUITARY RONGEUR 9569565
• Type of Device: INSTRUMENT, CUTTING, RONGEUR
• Manufacturer (Section D): MEDTRONIC ADVANCED ENERGY, LLC; 180 international drive; portsmouth NH 03801
• MDR Report Key: 7288824
• MDR Text Key: 100883184
• Report Number: MW5075401
• Device Sequence Number: 1
• Product Code: HAE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9569565
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR